tamoxifen compared with ly353381 in treating women with newly diagnosed breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can stimulate the growth of breast cancer cells. hormone therapy using tamoxifen or ly353381 may fight breast cancer by blocking the use of estrogen. purpose: this randomized phase i trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with ly353381, in treating women with newly diagnosed breast cancer.

objectives: * determine whether ly353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. * phase i: patients are randomized to receive either oral ly353381 hydrochloride or oral placebo daily. upon completion of phase i, all treatment centers begin phase ii of the study. * phase ii: patients are randomized to receive either oral tamoxifen or oral placebo daily. treatment in both phases continues for 2-6 weeks (until scheduled lumpectomy or mastectomy) in the absence of disease progression or unacceptable toxicity. patients are followed at 1 and 2 weeks after surgery. projected accrual: a minimum of 120 patients (60 per treatment phase) will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed noninvasive or small invasive breast cancer * low or intermediate grade (ductal carcinoma in situ, t1, or t2) or * estrogen and/or progesterone receptor positive * largest mass no greater than 5 cm * clustered microcalcifications as only abnormality allowed with no upper size limit * if no distinction between mass and microcalcifications, size as 1 lesion * lumpectomy or mastectomy must be planned for 2-6 weeks from start of study * no evidence of metastases from any malignancy * hormone receptor status: * estrogen and progesterone receptor positive (unless low or intermediate grade tumor) patient characteristics: age: * 18 and over sex: * female menopausal status: * postmenopausal by one of the following: * prior oophorectomy * over age 50 with prior hysterectomy, ovaries remaining * uterus and ovaries intact and no menstrual period for more than 3 months performance status: * not specified life expectancy: * not specified hematopoietic: * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 10 g/dl * absolute granulocyte count greater than 1,000/mm\^3 hepatic: * albumin greater than 3 g/dl * bilirubin less than 1.5 mg/dl * ast less than 100 u/l * alkaline phosphatase less than 200 u/l renal: * creatinine less than 1.5 mg/dl cardiovascular: * no history of deep vein thrombosis pulmonary: * no prior pulmonary embolus other: * not pregnant or nursing prior concurrent therapy: biologic therapy: * not specified chemotherapy: * at least 1 year since prior chemotherapy endocrine therapy: * at least 1 year since prior aromatase inhibitors, antiestrogens, or lh agonists/antagonists * no concurrent hormone replacement therapy or oral contraceptives (from time of randomization) radiotherapy: * not specified surgery: * see disease characteristics other: * no concurrent treatment for other malignancy

Keywords: stage i breast cancer stage ii breast cancer ductal breast carcinoma in situ breast cancer in situ